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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS PIP SZ. 30 PROXIMAL
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ASCENSION ORTHOPEDICS PIP SZ. 30 PROXIMAL Back to Search Results
Catalog Number PIP-200-30P-WW
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/23/2014
Event Type  malfunction  
Event Description
It was reported the device broke during a procedure, leaving the stem stuck in the pt.The physician was able to remove all but a 1mm piece.It was reported no injury is alleged.Add'l info received: the procedure was a pyrocarbon pip arthroplasty performed on (b)(6) 2014.There were no add'l complications.The 1mm piece remains implanted but the pt is doing well as far as i've heard.Pictures were taken and sent to product investigator.
 
Manufacturer Narrative
The device involved in the reported incident has been returned.The device eval is in progress.The result of the device eval will be reported in a follow up mdr submission.
 
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Brand Name
PIP SZ. 30 PROXIMAL
Type of Device
PIP
Manufacturer (Section D)
ASCENSION ORTHOPEDICS
austin TX 78754
Manufacturer Contact
maria leonard
311 enterprise dr
plainsboro, NJ 08536
6099362341
MDR Report Key4441523
MDR Text Key20299443
Report Number1651501-2015-00001
Device Sequence Number1
Product Code KYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
H010005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPIP-200-30P-WW
Device Lot Number141521T
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/23/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age62 YR
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